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HEALTH NEWS

FDA May Approve OTC Sales of Plan B Contraceptive

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Contributed by Nicole Weaver|  31 July, 2006  20:07 GMT

plan b morning after otc contraceptive
US health officials made a surprise about-face with Monday's announcement that they intend to move forward with plans to make the Plan B contraceptive available over-the-counter to women 18 and older.
In an unanticipated move, the US Food and Drug Administration announced Monday that over-the-counter sale of the Plan B "morning-after" piill could be approved for women over 18 within a matter of weeks. The issue has been the subject of controversy and debate for several years.

Barr Pharmaceuticals Inc., which manufactures the drug, applied for OTC approval of Plan B three years ago. Foes are opposed to broadening availability of the contraceptive, which contains an ingredient used in prescription birth control pills, but in a higher dose. Like other birth control pills, Plan B is currently available to all women as a prescription drug.

Senators: 'Another Delay Tactic'

In a letter to Barr subsidiary Duramed, the FDA suggested than Plan B pills would be kept behind pharmacy counters even if they were approved for OTC sale. Women would still have to ask for them, and anyone younger than 18 still would require a prescription.

The decision to consider making the prescription drug more easily accessible coincides with Senate confirmation hearings on President Bush's nominee to head the agency. Dr. Andrew C. von Eschenbach is scheduled to appear before the Senate on Tuesday.

Calling Monday's announcement "nothing more than another delay tactic," Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York, both Democrats, promised to block a vote on von Eschenbach's nomination unless the FDA makes a final decision on OTC Plan B sales.

Political Interference or Thoughtful Policymaking?

The FDA indefinitely postponed a decision on the controversy in 2005, outraging proponents of Plan B over-the-counter sales who felt that political conservatives had hijacked the decision-making promise. An FDA advisory panel had recommended OTC sales by a vote of 23 to 4 -- with no age restrictions -- as early as December 2003.

The FDA has said that its actions over the Plan B application were based on scientific or regulatory concerns. However, top agency officials reportedly decided at one point to reject the application before the staff

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